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Krzywanski et al., 2004)

Search authorised UK medicines Human Medicines Regulations 2012, Regulation 279

Biochemical and Biophysical Research Communications, 366 (4), 892897

Reviews from the originating group refer to the peptide having been used in small early-stage human studies in inflammatory bowel disease and other settings with no reported toxicity, but these were limited in size and scope and do not constitute the kind of controlled safety-and-tolerability program (single- and multiple-ascending-dose Phase 1 studies with systematic adverse-event capture) that establishes a human safety profile

No large-scale Phase III clinical trials have been completed in humans, and long-term safety data in human subjects is lacking